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This interactive course with workshops is designed to bring you up-to-date with regulatory requirements regarding Quality and Technical Agreements. You get to know a practical approach, applicable for contract givers and acceptors, to establish, implement and update these agreements.
Functions involved in the establishment, implementation and updating of Quality and Technical Agreements or auditing of implemented arrangements
08:30 - 09:00
Registration & coffee
09:00 - 12:00
per participant (excl. VAT)
✓ Exclusive learning approach
✓ Personal course documentation
✓ Lunch, water, coffee & tea
✓ Course certificate after completion
Quastion Learning Center (Qplus consult BVBA)
Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium
Roadmap for a practical Approach
How to start and what do I need?
Who is involved?
Which activities require a Quality and Technical Agreement?
GMP and GDP Requirements
Duties and responsibilities of contract giver and contract acceptor
Correctly defined, agreed and controller contracted services
Structure & Content of Agreements
How to create own template
Role of QA and Qualified Person/Responsible Person for GDP
Basic principles of contractual obligations and responsibilities
Content of agreement
Timelines and targets
Service/commercial agreements vs Quality and Technical Agreements
Common Pitfalls and how to avoid them
Expectations of the Health Authorities
The most common pitfalls and tools to avoid them
Implementation of the Quality and Technical Agreement arrangements into your own quality system
How to evaluate and document your compliance to the agreed arrangements
Duties and Responsibilities of Contract Giver and Contract Acceptor